FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHOLESTEROL
K Number: K771833
·
Decision Oct 18, 1977
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
10
Applicant Total
23
Review Days
27
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CHOLESTEROL
- K Number
- K771833
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1175
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Gamma Enterprises, Inc.
- Date Received
- September 21, 1977
- Decision Date
- October 18, 1977
- Product Code
- CGO
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CGO | Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CGO), ordered by most recent decision date.
CHOLESTEROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
KING DIAGNOSTICS CHOLESTEROL TEST
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CHOLESTEROL REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
REAGENTS FOR DETERM. CHOLESTEROL/SERUM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CHOLESTEROL DET. IN SERUM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SR-PLUS DIRECT CHOLESTEROL TEST
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Gamma Enterprises, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K790578 | GAMMA SMAC REAGENTS | May 15, 1979 | Substantially Equivalent |
| K780507 | SERUM GLUTAMIC-PYRUVIC TRANSAMINASE | May 3, 1978 | Substantially Equivalent |
| K780505 | SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE | May 3, 1978 | Substantially Equivalent |
| K780504 | CREATINE PHOSPHOKINASE (CPK) | May 3, 1978 | Substantially Equivalent |
| K780506 | CARBON DIOXIDE REAGENTS | May 3, 1978 | Substantially Equivalent |
| K771843 | WETTING AGENTS | Nov 22, 1977 | Substantially Equivalent |
| K771832 | CHLORIDE | Nov 22, 1977 | Substantially Equivalent |
| K771836 | LACTATE DEHYDROGENASE | Nov 22, 1977 | Substantially Equivalent |
| K771834 | CREATININE | Nov 3, 1977 | Substantially Equivalent |
| K771838 | SERUM IRON | Nov 3, 1977 | Substantially Equivalent |